New Delhi: The roll out of Russia’s Covid-19 vaccine ‘Sputnik V’ in India will be decided by the Subject Expert Committee (SEC) of the Indian drug regulator in a meet on Tuesday, as per a news agency report. Drugmaker Dr Reddy’s had last week submitted the safety and immunogenicity data the SEC had asked in the first meeting held on February 24.
“Meeting of Subject Expert Committee to be held today to deliberate on emergency use authorisation application of Russian vaccine Sputnik V. The vaccine manufacturers in India, Dr Reddy’s, have already submitted the safety and immunogenicity data of the third phase trials,” the news agency tweeted.
Meeting of Subject Expert Committee to be held today to deliberate on emergency use authorisation application of Russian vaccine Sputnik V
The vaccine manufacturers in India, Dr Reddy’s, have already submitted the safety and immunogenicity data of the third phase trials
— ANI (@ANI) March 31, 2021
Dr Reddy’s had entered into a partnership with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and had also applied for emergency approval for its covid vaccine. The company had conducted Phase 2 trials in India with around 1,500 participants. Phase 3 trials are still underway.
“We expect to get the approval in the next few weeks. It is a two-dose vaccine. You take the first dose on day zero and the second one on day 21. The peak immunity develops somewhere between day 28 to day 42. So, it is a two-dose vaccine and we expect it to be available in the next few weeks,” Deepak Sapra, the company’s CEO was quoted saying.
Notably, India already has two approved COVID-19 vaccines – Covishield and Covaxin- that are currently being administered to eligible Indians.
So far, frontline and healthcare workers, as well as people above 60 years of age and people over 45 years of age with co-morbidities, were being administered the vaccines. Now, from 1 April, the vaccination drive will cover everyone over 45 years of age.
As per latest reports, with 53,480 fresh infections India’s COVID-19 tally has reached 1,21,49,335. While 354 new fatalities have also contributed to the Corona scare in the country, taking the death toll to 1,62,468, according to Union health ministry data updated on Wednesday. The active caseload increased to 5,52,566, the ministry data updated at 8 am showed.
Meanwhile, the Sputnik V vaccine has proven equally effective for all age groups, Alexander Gintsburg, the head of the Gamaleya research institute that developed the vaccine, has said. “Sputnik V demonstrated the same level of efficacy in all age groups. At first, there were doubts that the efficacy in people aged 60 and over would be lower … but it was absolutely not,” Gintsburg said in a show on YouTube.
To note, ‘Sputnik V’ is being developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology to fight against Covid-19 based on the human adenoviral vector platform.